Endosurgical ultrasonic probe with integrated biopsy actuator

ABSTRACT

A medical endosurgical device is provided having both ultrasonic imaging and biopsy capabilities for easy grasping and manipulation by a surgeon. The medical endosurgical apparatus includes an ultrasonic imaging probe having an insertion portion with an ultrasonic device near the insertion tip and a probe handle for manipulating the ultrasonic imaging probe to position the ultrasonic device in the patient&#39;s body. The medical endosurgical device also includes a biopsy actuator that is mounted on the handle of the ultrasonic imaging probe so that a biopsy needle assembly exiting from the biopsy actuator is oriented to the field of view of the ultrasonic device on the probe. The medical endosurgical apparatus may also include a rigid sheath disposed over the insertion portion of the ultrasonic imaging probe that is engaged with and oriented to the ultrasonic imaging probe such that a biopsy needle assembly passing through a lumen in the rigid sheath would be oriented to the field of view of the ultrasonic device.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 07/989,515 by Oakley et al. filed Dec. 11, 1992 now U.S. Pat.No. 5,.335,663.

FIELD OF THE INVENTION

The present invention relates to medical surgical apparatus that areparticularly suited for use in endosurgery.

BACKGROUND OF THE INVENTION

Ultrasonic imaging has found several applications in the medical field,especially to view internal anatomical tissue and structures. One wellknown application, for example, is to use a hand held ultrasonic probeto image a developing fetus during pregnancy. Ultrasonic imaging hasalso found application in laparoscopic surgery, such as in theperformance of biopsies and excision of internal organs or other tissue.

Endosurgery involves the use of small diameter tools that are insertedinto a patient's body through a small, unnatural hole or surgical port,that is established by puncturing the external tissue of an organ, suchas the skin. As used herein, endosurgery includes all surgicaloperations performed through a surgical port, including laparoscopic,thorascopic, pelviscopic and extraperitoneal surgical approaches. By wayof example, specific discussions of laparoscopic operations are usedhereinafter. It should be recognized, however, that the discussionsconcerning laparoscopic operations apply equally to other forms ofendosurgery, including thorascopic, pelviscopic, and extraperitonealoperations. In laparoscopic surgery, the hole is made by puncturing theabdominal wall with a sharp edged instrument called a trocar. A smallworking tube, called a cannula, is then inserted into the hole to holdit open. Through the internal passageway of the cannula, referred to asa surgical port, are passed the necessary instruments into the bodycavity to perform desired surgical operations.

Normally, the trocar and cannula are configured in a single structure.Also, the cannula is usually fitted inside with some type of sealingapparatus, such as, for example, a flapper valve that can be forced openby a tool entering through the cannula, and which springs closed to sealthe internal passageway through the cannula when not in use. The cannulacan also be fitted with annular sealing devices for sealing between aprobe inserted through the cannula and the inside wall of the cannula.Such a means for sealing the passageway of the cannula preventscontaminants from the outside environment from invading the body cavity,thereby reducing the possibility of infection.

Various probes have been used to aid laparoscopic surgical operations.For example, optical probes are often used to view the outer surfaces ofinternal organs. Also, ultrasonic probes have been used to assist inviewing the internal structures of organs to obtain information that maybe necessary for performance of certain surgical operations. Forexample, a surgeon might need to be able to identify and distinguish thecystic duct from the common duct in the gall bladder/liver to performcertain procedures.

One common laparoscopic procedure is a biopsy, in which a sample oftissue is taken from inside a patient's body. Presently, the taking of abiopsy involves the manipulation and coordination of several probes.Typically, a video television probe is inserted into the patient. Thevideo probe is used to provide the surgeon with a picture of the surfacetissue of various structures within the patient. In many cases, anultrasonic probe is also inserted into the patient to obtain anultrasonic image of the tissue underlying the surface tissue identifiedwith the visual probe. After locating the underlying tissue of interest,a biopsy needle is then inserted into the patient's body. The surgeondirects the tip of the biopsy needle to the underlying tissue ofinterest using the ultrasonic image and video image for reference. Oncethe biopsy needle is positioned in the proper location near the tissueof interest, then the biopsy needle is fired by a biopsy gun locatedoutside of the patient's body. Throughout the positioning of the biopsyneedle in the patient's body and the firing of the biopsy gun, thesurgeon must coordinate manipulation and positioning of the ultrasonicprobe and/or the video probe with one hand and the biopsy gun with theother hand, while simultaneously viewing the ultrasonic image of thetissue of interest and/or the video image. Accurately manipulating andpositioning the ultrasonic probe, video probe and the biopsy gun whileconcentrating on the noted images is difficult. Therefore, there issignificant risk that the surgeon will sample the wrong tissue, therebyrequiring an additional biopsy procedure to obtain a sample of theproper tissue.

A need exists for laparoscopic surgical medical apparatuses that reducethe risks of a surgeon taking samples of the wrong tissue.

A variety of ultrasonic probes have been used in laparoscopicprocedures. One type of probe has a single transducer that ismechanically moved through an arc to transmit or receive ultrasonicsignals over a pie-shaped area. Such a mechanical sector scanner can bepositioned on a probe to image in either a forward or a side direction.A second type of ultrasonic probe that is used to transmit or receiveultrasonic signals over an area contains several transducer elementsarranged in an array. One type of array probe that has been usedcontains several transducers arranged in a line along the side of acylindrically shaped probe. Such a linear array provides side imagingcapability. Another type of array probe aligns the array of transducerelements along a curve at or near the end of a probe to provide forwardlooking capability. Such a curved array transmits and receivesultrasonic signals over a pie-shaped area like the mechanical sectorscanner. Although working well for forward viewing that is useful as ageneral directional and positional guide, curved arrays are not wellsuited for imaging near the probe, as is often desirable during surgery,because of a limited field of imaging in the region near the curvedarray.

During laparoscopic surgical operations, ultrasonic imaging in a forwarddirection beyond the end of the probe is often required. Ultrasonicimaging to the side of the probe, however, is also often required. Theability to do both forward and side imaging are desirable during someoperations. For example, forward imaging can be used to determine when aprobe is at the location in the body cavity for side imaging organs orother tissue of interest which cannot be adequately viewed with aforward imaging probe.

Typically, when a need exists for both forward and side imaging, twoseparate probes are used, one for forward imaging and one for sideimaging. For example, a forward imaging probe might first be inserted sothat a surgeon can determine the proper distance into the body cavity atwhich the operation is generally to be performed and possibly also tolocate an organ or other tissue of interest. The forward imaging probeis then removed and a side imaging probe is inserted to obtain a betterview of the organ or other tissue of interest in preparation for amedical operation that is to be performed on the tissue, such asexcising tissue or taking a biopsy sample. The use of two probes,however, is awkward. It is difficult for a surgeon performing a complexoperation to mentally reorient between the forward and side lookingimages. Also, assuring proper repositioning of the probe at the properdistance into the body cavity can present a problem.

One attempt to provide some degree of both forward and side lookingcapability in a single probe has been to place a linear array at someacute angle relative to the longitudinal axis of the probe. Such anangled array, however, provides limited imaging capability in either theforward or the side directions, and is, therefore, of limited practicalutility.

Another attempt to provide some degree of both forward and side lookingcapability in a single probe has used a mechanically scanned ultrasonictransducer. These probes, like the probes using the angled array, haveproved to be of limited practical utility due to their limited imagingcapability in the forward and side directions. Moreover, the movingparts associated with mechanical scanners render the probes moresusceptible to malfunction.

Based on the foregoing, there is a need for an ultrasonic probe thataddresses the noted deficiencies of presently known probes in providingboth forward and side imaging capability.

Presently, ultrasonic images produced by ultrasonic medical probes aredisplayed on a video monitor with a fixed frame of reference. The imageis typically displayed on the monitor from top to bottom, with thedistance away from the ultrasonic probe increasing going down thescreen. Therefore, tissue nearest the ultrasonic probe is displayed atthe top of the monitor and tissue farthest from the probe appears at thebottom of the monitor.

A surgeon, or other medical professional, viewing the ultrasound imagemust mentally translate the image as displayed on the monitor to a frameof reference in the patient's body, thereby orienting the image in orderto properly locate organs or other tissue of interest. Also, when theprobe is moved from one position to another, or rotated to image in adifferent plane, the surgeon must also mentally reorient that new imagerelative to the old image. For example, if the surgeon is viewing afirst ultrasonic image with the probe in a first position lookingsideways and then rotates the probe counterclockwise to produce a secondimage, the surgeon must mentally translate the second imagecounterclockwise from the first image to properly conceptualize thepatient's anatomy. These mental translations and orientations of imagescan be difficult to make as well as potentially distracting duringcomplex surgical operations.

Consequently, there exists a need to provide the surgeon with anultrasonic image that reduces the mental image translations that thesurgeon must presently make each time the probe is moved to obtain a newimage.

Many laparoscopic surgical operations require cutting, or excision, ofinternal tissue. The tissue to be cut as well as other internalstructures must be located and properly identified prior to performingthe cutting operation. For example, it may be necessary to locate andidentify the common duct that runs through the liver so that asubsequent cutting operation on the liver will not nick or sever theduct.

Presently known methods for performing cutting operations duringlaparoscopic surgery use techniques for locating and identifying tissuethat present significant potential for cutting the wrong tissue. Forinstance, one method for locating, identifying, and cutting tissueinvolves inserting an ultrasonic probe into the patient's body cavity tolocate and identify the tissue to be cut and internal structures to beavoided. The ultrasonic probe is then removed and a surgical instrumentis inserted and positioned to perform the cutting based on theinformation obtained from the ultrasonic probe. Positioning the surgicaltool to properly perform the desired cut, however, based upon theinformation provided by the ultrasonic probe may be difficult, and it ispossible that an improper cut can be made.

Therefore, a need exists for reducing the possibility that an impropercut or excision is made.

One problem often encountered with performing ultrasonic scans duringlaparoscopic operations is establishing good ultrasonic contact betweenultrasonic transducers and tissue, the underlying structure of which isto be imaged. Good ultrasonic images can be produced only if adequateultrasonic contract, often referred to as coupling, can be made betweenthe tissue and ultrasonic transducers. Obtaining such ultrasonic contactis often difficult. For example, an ultrasonic device may be on the sideof a probe, but only the tip of the probe can be contacted with thetissue of interest. Or, for example, it may be possible to contact theultrasonic device and the tissue of interest, but in so doing the tissueis physically distorted and, therefore, the ultrasound image producedmay be misleading.

One approach that has been used to establish ultrasonic contact withtissue is to fill the body cavity space in which the tissue resides withan ultrasonically transmissive fluid, such as water. However, thistechnique results in large amounts of transmissive fluid invading thebody cavity. Transmissive fluids placed in the body cavity must normallybe removed following the ultrasonic imaging operation. Assuring thatlarge amounts of transmissive fluid have been completely removed fromthe body cavity can be troublesome.

Another problem with laparoscopic probes is that they are difficult tosterilize. One attempt to resolve the sterilization problem has been toplace a sterile disposable cover, or sheath, over the laparoscopic probeprior to insertion of the probe into a body cavity. After removal of theprobe, the sheath is discarded. As a consequence, the need for extensivesterilization of the probe is reduced.

One type of sheath that has been used to cover laparoscopic probes is aloose fitting, thin-walled, highly flexible prophylactic sheath made ofan elastomeric-type material, such as latex rubber. One problem with theloose fitting prophylactic sheath however, is that it tends to catch andbind in the seals and/or a flapper valve in the cannula therebyinhibiting insertion and extraction of the probe. In extreme cases, theprophylactic sheath may tear, thereby defeating the very purpose of thesheath in providing a sterilized surface.

Another type of sheath that has been used is a thin-walled, tightlyfitting, highly flexible sheath made of elastomeric-type material, suchas latex rubber. The sheath is fitted on the probe by first inflatingthe sheath, like a balloon, and then inserting the probe into theinflated sheath. The sheath is then deflated to tightly fit around theprobe. Because of the thin-walled, highly flexible nature of the sheath,however, there is still potential for binding in the cannula. Also, theprocedure of fitting the sheath onto a probe is time consuming andawkward in the surgical environment. One related problem with using thesheaths just discussed, is assuring that an ultrasonically transmissivecircuit is established between the ultrasonic device and the sheath.Currently, ultrasonic coupling between the ultrasonic device and thesheath is established by coating the probe with an ultrasonicallytransmissive fluid before covering the probe with a sheath. Thisprocedure, however, is inconvenient, time consuming and awkward in theenvironment of an operating room.

Based on the foregoing, there is a need for establishing an ultrasonicdevice that can ultrasonically couple the transducer to the tissue ofinterest that avoids or reduces the problems associated with using largeamounts of ultrasonically transmissive material to establish therequisite coupling.

SUMMARY OF THE INVENTION

One aspect of the present invention addresses the need for providingultrasonic imaging capability and biopsy capability in a manner tosimplify the taking of an accurate biopsy sample during endosurgery. Inone embodiment, the apparatus comprises an endosurgical ultrasonicimaging probe having an ultrasonic device that is located on a portionof the probe which is inserted through a surgical port and is used toultrasonically image tissue in a patient's body. Physicallyinterconnected to the probe handle is an automated biopsy gun foractuating a biopsy needle assembly to take a biopsy sample with a needletip of the biopsy needle assembly. In one embodiment, the probe handleand biopsy gun are interconnected and, together, have a contoured shapethat permits a surgeon to comfortably grasp and manipulate both theprobe handle and the biopsy gun with one hand, thereby reducing thenumber of separate surgical instruments that the surgeon must keep trackof during a biopsy.

In another embodiment, the automated biopsy gun is interconnected to thehandle of the ultrasonic imaging probe by a slot located on one of theprobe handle and the automated biopsy gun and a rail located on theother of the probe handle and the automated biopsy gun, facilitatingeasy connection and disconnection of the automated biopsy gun with theprobe handle. The biopsy actuator device physically interconnected tothe handle of the ultrasonic imaging probe with such a slot/railengagement can be moved longitudinally along the probe handle toaccommodate longitudinal placement of a biopsy needle tip relative to anultrasonic device in a patient's body. Because the automated biopsy gunis not permitted by the slot/rail engagement to move laterally relativeto the probe handle, however, the biopsy needle tip remains aligned withthe imaging plane of the ultrasonic device in the patient's body. In oneembodiment, the automated biopsy gun has a locking mechanism that locksthe biopsy gun in place on the handle of the ultrasonic imaging probe.The locking mechanism allows the surgeon to fix the relative positionsof the ultrasonic imaging probe and the biopsy gun once the needle tipof the biopsy needle assembly has been properly positioned relative tothe ultrasonic device, thereby preventing the biopsy needle tip frommoving while the surgeon prepares for and takes a biopsy sample usingthe biopsy gun.

In another embodiment, the biopsy gun includes cocking grips mounted inpairs on opposite sides of the automated biopsy gun to facilitatecocking of the biopsy gun. For example, the opposing cocking gripspermit the surgeon to obtain a firm grip for cocking the biopsy gunwithout moving the ultrasonic imaging probe and the biopsy needle tipthat has been properly positioned to take a biopsy sample.

In one embodiment, the ultrasonic imaging probe has a keyed structurefor use in holding a rigid sheath in place that may be fitted over theinsertion portion of the ultrasonic imaging probe. In anotherembodiment, the rigid sheath is connected to the ultrasonic imagingprobe with a keyed engagement shape so that a lumen through the rigidsheath is oriented to the imaging plane of the ultrasonic device. Asurgical tool, such as a biopsy needle assembly, passing through thelumen is thereby oriented so as to pass within the imaging plane of theultrasonic device upon exiting the lumen.

In another aspect, the present invention provides an ultrasonic imagingprobe having both forward and side imaging capabilities on a singleprobe. The probe comprises a carrier and an array of ultrasonictransducers capable of imaging in a forward direction beyond the end ofthe end portion of the probe that is inserted into the patient's body.The ultrasonic array includes a first array portion that includes atleast one ultrasonic transducer oriented to image at an acute anglerelative to the longitudinal axis of the carrier such that thetransducer images in a forward direction beyond the end of the probe.The array also includes a second portion having a plurality ofultrasonic transducers arranged in a substantially linear fashion andsubstantially parallel to the longitudinal axis of the carrier for sideimaging.

In a further embodiment, the first array portion includes a plurality oftransducers that are oriented so as to define a substantially planarcurve, i.e., a curve that lies substantially in a single plane. In oneembodiment, the planar curve has a large radius of curvature thatextends over an acute included angle, thereby facilitating manufactureof the probe by making electrical connections to individual transducerelements easier to make. Alternatively the planar curve can have anincreasing radius of curvature. By having a large radius of curvature,thereby decreasing the angle in which the curve is included, or byhaving an increasing radius of curvature, additional room is provided tomake electrical connections to individual elements over the length ofthe curve. This can be particularly advantageous when the radius of thecarrier is very small, such as with instruments used in laparoscopicsurgery.

In a still further embodiment, the carrier of the probe is substantiallycylindrical over much of its length, with the substantially circularcross section defining the areal boundary, perpendicular to thelongitudinal axis, within which all portions of the probe must lie. Inone embodiment, the transducer elements of the second array portion,arranged substantially in a line parallel with the longitudinal axis,are recessed relative to the areal boundary, thereby permitting othersurgical tools, such as a biopsy needle, to be located within or passedthrough the recess. Moreover, those other surgical tools can bepositioned within the imaging field of the linear portion of the array,thereby allowing a surgeon to simultaneously obtain an image of both thebody tissue of interest and the surgical tool.

Another embodiment of the invention provides an ultrasonic imagingapparatus that addresses the mental translations and reorientations thatsurgeons must make with respect to the display of present ultrasonicimages. The ultrasonic imaging apparatus includes an ultrasonic probewith at least one ultrasonic element that transmits a first electricalsignal, representative of a received ultrasonic signal, a positionsensor that produces a second electrical signal representative of theposition of the probe, a processor for constructing a video image of theultrasonic signal for display on a video monitor from the firstelectrical signal and manipulating the video image using the secondelectrical signal to reflect the orientation of the ultrasound image.For example, a first video image could be displayed on a video monitorrepresenting an ultrasound image produced at a first position with aside imaging ultrasound probe. The probe could then be rotatedcounterclockwise to a second side imaging position. The second videoimage is rotated counterclockwise on the video monitor relative to thefirst video image thereby relieving the surgeon from having to make themental adjustment in the image. In one embodiment, both a rotationalposition sensor and a translational position sensor are provided so thatboth rotations and translations of images can be effected.

Yet another embodiment includes a device for establishing a referencepoint for the position sensor that relates to a patient's body so thatthe ultrasound image displayed on a video monitor can be oriented to thepatient. For example, if the reference point is the patient's head, theposition sensor can produce data that allows a video image to beconstructed in which the top of the video monitor corresponds to thepatient's head and the bottom of the video monitor corresponds to thepatients feet, regardless of the direction in which the ultrasonic probeis imaging.

One embodiment of the invention is directed to the problem locating oridentifying the tissue of interest and then performing a cutting orother surgical operation. In an embodiment, the invention provides alaparoscopic probe that includes both a surgical device for cuttingand/or cauterizing tissue and an ultrasonic device with a field ofimaging that either includes the surgical device or is immediatelyadjacent to the surgical device. Because the surgical device is integralwith the probe containing the ultrasonic device and is proximatelylocated to the ultrasonic device, the surgeon is less likely to makeimproper cuts. In one embodiment, the surgical device includes anelectrocautery hook that is positioned within or adjacent to theultrasonic field of imaging of an ultrasonic array. Using the ultrasonicimage, a surgeon can locate and identify the proper tissue for cuttingas well as the internal structures that are not to be cut. Afterlocating the proper tissue, the surgeon can activate the electrocauteryhook and, because of the overlapping or immediately adjacent field ofimaging, can closely control the precise position at which the cut ismade.

A further embodiment of the present invention addresses the need toestablish ultrasonic contact between an ultrasonic device and tissue ofinterest. The apparatus comprises a carrier, an ultrasonic devicemounted on the carrier, and a device for use in injecting anultrasonically transmissive medium adjacent to the ultrasonic device.The transmissive medium is placed in the vicinity of the ultrasonicdevice for the purpose of establishing an ultrasonic circuit, or bridge,with the tissue that is located in the field of view of the ultrasonicdevice.

In one embodiment, a high viscosity fluid is used as the transmissivemedium. High viscosity fluids have the advantage that the medium has areduced tendency, relative to lower viscosity fluids, to disperse orflow away from an area immediately adjacent to the ultrasonic device.Consequently, a relatively small amount of such high viscosity fluid canbe used to provide the necessary ultrasonic contact for imaging thetissue of interest. The result is that a relatively small amount oftransmissive medium is used which is relatively easy to remove from thebody following ultrasonic imaging. Ease of removal is facilitated by thesmall amount of medium and an increased tendency of high viscositymedium to remain in the vicinity of the ultrasonic device. In oneembodiment, the transmissive medium adheres to the outer surfaces of thecarrier and ultrasonic device and does not disperse or flow away fromthat immediate vicinity.

One embodiment of the present invention provides a disposable sheath forcovering a probe that is to be inserted into a patient's body cavity. Inone embodiment, the sheath is a rigid structure that substantiallyreduces, or eliminates, any problem with binding of the sheath in thecannula as has been experienced with the thin walled, highly flexible,elastomeric-type sheaths of the prior art.

Another embodiment of the sheath includes a chamber within the sheath.The chamber contains an ultrasonically transmissive medium and is sealedwith a breakable membrane. When a probe is inserted into the sheath, theprobe breaks the membrane and the ultrasonic device of the probe entersthe chamber containing the ultrasonically transmissive medium. Anultrasonic circuit is thereby established between the ultrasonic deviceand the sheath.

Another embodiment of the sheath includes an inflatable balloon at ornear a first terminal end of the sheath that is inserted into thepatient's body cavity. The balloon can be inflated with anultrasonically transmissive medium to establish an ultrasonic circuitbetween an ultrasonic device of the probe inserted into the sheath andtissue to be ultrasonically scanned.

Another embodiment of the sheath is shaped to establish a desiredorientation between the ultrasonic probe and the sheath. Orientation issuch that the ultrasonic device of the probe is always adjacent to oneor more lumens through which ultrasonically transmissive medium can betransmitted to and injected immediately adjacent the sheath in thedirection of the ultrasonic beam. An ultrasonic circuit between thesheath and tissue of interest is established by the excreted medium.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B show a side view and a top view of a probe containing a90° curved first array portion and a linear second array portion of anultrasonic transducer array, which second array portion is recessed toallow for passage of a surgical tool, such as a biopsy needle;

FIGS. 2A and 2B show a side view and end view of a probe having both acurved first array portion and a linear second array portion of anultrasonic transducer array, with the curved first array portionincluded within an acute angle and having an enlarged radius ofcurvature to facilitate the making of electrical connections toindividual transducer elements;

FIG. 3 shows a side view of a probe having an ultrasonic transducerarray comprised of a 180° curved first array portion and two lineararray portions;

FIG. 4 shows an apparatus for use in performing ultrasonic imaging thatincludes translational and rotational position sensing devices forsensing the position of an ultrasonic probe and using the positioninformation to manipulate the displayed ultrasonic video image;

FIG. 5 shows a mercury switch that can be used to sense rotationalposition of a probe based on gravitational force;

FIG. 6 shows a probe having an ultrasonic transducer array and anelectrocautery hook located partially within the field of imaging of thearray;

FIG. 7 shows a laparoscopic probe having an ultrasonic array and lumensfor injecting transmissive fluid in the vicinity of an ultrasonictransducer array;

FIG. 8 shows a cross section of a probe having means for injectingtransmissive fluid adjacent to an ultrasonic transducer array;

FIGS. 9A and 9B show a perspective view and a cross sectional view alongthe longitudinal axis of a first embodiment of a rigid sheath;

FIGS. 10A and 10B show a cross section along the longitudinal axis and across section perpendicular to the longitudinal axis of a secondembodiment of a rigid sheath that also has a lumen that can be used forvarious purposes;

FIG. 11 shows another embodiment of the sheath having a chamber filledwith transmissive medium and sealed with a breakable membrane;

FIG. 12 shows the sheath of FIG. 11 in which the sealing membrane hasbeen broken and a probe has been inserted into the chamber;

FIG. 13 shows another embodiment of the sheath having a balloon on theend that can be inflated with an ultrasonically transmissive mediumthrough a lumen in the sheath;

FIG. 14 shows the sheath of FIG. 13 with the balloon inflated withultrasonically transmissive medium and in which an ultrasonic probe hasbeen inserted;

FIG. 15 shows a cross section of a sheath having lumens for placingtransmissive medium in a area to be ultrasonically imaged;

FIG. 16 is a perspective view in expanded form of a medical surgicalapparatus including an ultrasonic imaging probe;

FIG. 17 is a side view of one embodiment of an ultrasonic imaging probe;

FIG. 18 is a sectional view of the handle of one embodiment of anultrasonic imaging probe;

FIG. 19 shows a sectional view of a keyed engagement shape for engaginga rigid sheath of one embodiment of an ultrasonic imaging probe;

FIG. 20 is a top view of one embodiment of an ultrasonic imaging probe;

FIG. 21 is a side view of a biopsy needle assembly;

FIG. 22 is a side view of one embodiment of a rigid sheath;

FIG. 23A is a sectional view of one embodiment of a rigid sheath showinga lumen inside the sheath;

FIG. 23B is a sectional view of one embodiment of a rigid sheath showinga lumen in the wall of the rigid sheath;

FIG. 24 is a sectional view of one embodiment of a rigid sheath showinga connection clip in the shape of a hollow lip;

FIG. 25 is an end view of one embodiment of a rigid sheath showing akeyed engaging shape for engaging an ultrasonic imaging probe;

FIG. 26 is a sectional view of an orientation guide on one embodiment ofa rigid sheath;

FIG. 27 is a side view of one embodiment of a rigid sheath having twoconnecting clips for engaging an ultrasonic imaging probe;

FIG. 28 is a bottom view of one embodiment of a rigid sheath having twoconnecting clips for engaging an ultrasonic imaging probe;

FIG. 29 is a side view of one embodiment of a biopsy actuator;

FIG. 30 is a front end view of one embodiment of a biopsy actuator;

FIG. 31 is a back end view of one embodiment of a biopsy actuator;

FIG. 32 is a cut-away of one embodiment of a biopsy actuator;

FIG. 33 is a sectional view showing one embodiment of a biopsy actuatorin a cocked position;

FIG. 34 is a perspective view of one embodiment of a biopsy actuator;

FIG. 35 is a partial top view of one embodiment of a biopsy actuatormounted on an ultrasonic imaging probe handle and having a safetydevice;

FIG. 36 is a partial sectional view of one embodiment of a biopsyactuator device mounted on an ultrasonic imaging probe handle having asafety device; and

FIG. 37 is a perspective view of an assembled medical surgical apparatusincluding an ultrasonic imaging probe, a rigid sheath and a biopsyactuator.

DETAILED DESCRIPTION

In one aspect, the present invention is an endosurgical ultrasonic probethat provides ultrasonic imaging both in a forward direction past theend of the probe that is inserted into a patient's body and also to theside of the probe. The probe is particularly suited for use inlaparoscopic, thorascopic, pelviscopic and extraperitoneal surgicaloperations.

FIGS. 1A and 1B show one embodiment of a probe. Probe 20 comprises acarrier having a longitudinal axis 22 extending between a first terminalend 24, which is inserted into the patient's body, and a second terminalend, not shown, which remains outside of the patient's body. Extendingthrough the carrier is a smaller diameter conduit 26, called a lumen,through which surgical tools, such as a biopsy needle 28, can betransmitted from outside of the patient's body to a recess area 30 nearthe first terminal end 24. Typically, such a carrier for a laparoscopicprobe would have a maximum cross sectional width smaller than about 12millimeters, and often from about 10 millimeters to about 12millimeters.

The probe 20 also has an array 32 of ultrasonic transducers comprising acurved first portion 34 and a linear second portion 36. The curvedportion 34 has at least one ultrasonic transducer that is situated toimage at an acute angle relative to the longitudinal axis 22.Preferably, the curved portion 34 comprises a plurality of ultrasonictransducer elements arranged in a planar curve. The curved portion 34shown in FIG. 1A is configured as a planar curve having a 90° includedangle and a radius of curvature 38, as shown.

The curved portion 34 is continuous with the linear portion 36, whichhas a plurality of ultrasonic transducer elements located substantiallyin a line that is substantially parallel to the longitudinal axis 22.The linear portion 36, therefore, produces an ultrasound image directedto the side of the probe. An array having a curved first portionextending over a 90° arc and a linear second portion, as shown in FIG.1A, has an ultrasound imaging pattern 40 extending from a full forwardimaging position at one end of the curved portion 34 to a full sideimaging position along the linear portion 36.

The array 32 is preferably located relative to the lumen 26 so that asurgical tool, such as a biopsy needle 28, exiting the lumen 26 willpass through the recess area 30 in such a manner that the tool passesthrough the field of view of the linear portion 36 of the array. If thetool exiting the lumen 26 is extended through the recess beyond thelinear portion 36, such tool would also preferably pass within the fieldof view of the curved portion 34 of the array. This ability to passsurgical tools directly to the vicinity of the array 32 can facilitateprecise placement of tools, such as biopsy needles, at the desired pointas located by the ultrasonic image produced by the array 32. Preferably,the array 32 has at least about thirty-two transducer elements, morepreferably at least about sixty-four transducer elements, and mostpreferably at least about one hundred and twenty-eight transducerelements. The relative number of transducer elements included in thecurved portion 34 relative to the linear portion 36 will depend upon thespecific embodiment and the relative needs for viewing beyond the firstterminal end of the carrier and viewing to the side of the carrier.Frequently, however, transducer elements will be equally split betweenthe two portions. Transducer elements are typically from about 3 mm toabout 5 mm long. The individual transducer elements can be spaced at anyconvenient distance from each other, providing that spacing is closeenough to provide adequate imaging. Frequently, transducer elements arespaced from about 0.1 mm to about 0.3 mm on center and preferably atabout 0.2 mm on center, with the longitudinal axis of the transducerelements extending into the internal space of the carrier. An array withone hundred twenty-eight transducers would, therefore, be approximatelyone inch long as measured along the surface of the array.

Viewing beyond the first terminal end of the probe using the curvedarray portion 34 is desirable to help determine what organs or othertissue lie in the path of the probe, to help determine when the probehas reached the proper distance into the patient's body, and to identifyorgans or tissue of interest. The side looking second portion 36 isparticularly suited for viewing a particular organ or other tissue oncethe probe has been positioned at the proper distance within thepatient's body.

FIGS. 2A and 2B show another embodiment of a laparoscopic ultrasonicprobe having features as previously described for the probe shown inFIGS. 1A and 1B, except as noted. The first portion 42 of the ultrasonictransducer array is shown as arranged in a planar curve having a largerradius of curvation than that shown in FIGS. 1A and 1B. Also, the curvedportion 42 has an acute included angle. Therefore, the curved firstportion 42 has a capability of imaging, as shown by the imaging pattern46, beyond the end of the probe that is somewhat restricted relative tothe 90° curved first portion 34 shown in FIG. 1A. The relatively flattercurve of the curved portion 42 relative to that shown in FIG. 1A is dueto the larger radius of curvature 48 that extends well beyond the edgeof the probe carrier, as shown.

The relatively flatter curve in the arc of curved portion 42, althoughsomewhat reducing the forward viewing capability of the array, has theadvantage of facilitating electrical connection of transducer wires 50to individual transducer elements in the curved first array portion 42.Such additional space for making electrical connections to individualtransducer elements can significantly decrease the cost of manufacturingthe probe. As an alternative to a larger radius of curvature, anincreasing radius of curvature can also be used. For example, the radiusof curvature of the curved array portion could be smallest at the end ofthe curved portion nearest the end of the probe and could increase,thereby flattening the curve, moving along the curved portion away fromthe end of the probe.

The probe shown in FIGS. 2A and 2B also has a lumen 52 extending throughthe carrier and through which surgical tools can be transmitted to arecessed area in the vicinity of the linear second array portion 54.

FIG. 3 shows another embodiment of an ultrasonic probe for use inlaparoscopic surgery. The first portion 56 of the array extends over afull semi-circle. Other configurations for the first portion that extendfrom one side of the probe to the other are also possible, and need notextend through a full 180° . Unlike the probes previously described,this probe contains two linear portions 58 and 60, thus providing animaging pattern 61 extending down two sides of the probe and completelyaround the front of the probe.

Another aspect of the present invention involves sensing the position ofan ultrasonic probe, generating an electrical signal representative ofthe position of the probe, and using that electrical signal to orient avideo display of an ultrasonic image generated by the probe.

FIG. 4 shows one embodiment of the invention. An ultrasonic probe 62with a longitudinal axis 64 having a first terminal end 66 that isinserted into a patient's body and a second terminal end 68 that isconnected to a handle 70, with which a surgeon would manipulate theprobe. The first terminal end 66 of the probe is inserted into thepatient's body through a hole in the abdominal cavity 72 that is heldopen by a tubular device 74, called a cannula, the internal passagewaythrough which is often referred to as a surgical port. An array 76having a plurality of ultrasonic transducers is located near the firstterminal end 66 of the probe. The ultrasonic transducers produce firstelectrical signals that are applied to a processor 78 that places thesignals in a form suitable for display as a video ultrasound image on avideo monitor 80. Electrical circuits for the ultrasound transducers arenot shown.

Mounted on the cannula adjacent to the surgical port are two positionsensors 84 and 86. A first position sensor 84 monitors the translationalposition of the probe 62 along the longitudinal axis 64. A secondposition sensor 86 monitors the rotational position of probe 62 aboutthe longitudinal axis 64.

The first positional sensor 84 generates an electrical signalrepresentative of the translational position of the probe which goes toa processor 78 and is used to manipulate ultrasound video images formedfrom the signals provided by the array 76. For example, the electricalsignal provided by the first positional sensor 84 can be used togenerate consecutive video ultrasound images to be displayedsequentially across the video monitor in proper spacial relationship toone another in a translational direction.

The second position sensor 86 generates an electrical signal that isrepresentative of the rotational portion of the probe which istransmitted to a processor 78 where the signal is used to manipulate andorient an ultrasound video image formed from the signals provided by thearray 76 relative to the rotational position of the array 76 on theprobe 62. For example, if the array 76 is imaging at a first positionand is subsequently rotated to a second position in a counterclockwisedirection, the ultrasound video image on the monitor 80 also rotates onthe video monitor screen in a counterclockwise direction.

In one embodiment, a reference point can be set so that a particulardirection on the video monitor represents a specific orientationrelative to the patient. For example, if a probe is inserted through thesurgical port and travels in a vertical direction into the body cavity,it may be desirable to select the top of the video monitor ascorresponding to the head of the patient. If the ultrasonic array isthen rotated to image in a direction towards the head, the portions ofthe image closest to the ultrasonic array will appear at the bottom ofthe video monitor and the portions of the image farthest from the array,being closer to the head, will appear at top of the video monitor. Ifthe probe is then rotated to image in a direction towards the feet, thenthose portions of the image closest to the probe will be near the top ofthe video monitor and those portions of the image farthest from theprobe will appear near the bottom of the video monitor. If the probe ispositioned to look to one side, or the other, of the patient's body thenportions of the image closest to the array would show near theappropriate side of the monitor.

If, however, a surgeon is inserting a probe through a surgical port thatenters the body mostly from the side such that the probe travels acrossthe body cavity, then it might be convenient for the surgeon to selectthe top of the screen as corresponding to the front the patient's body.The bottom of the screen would correspond to the back of the patient'sbody. The video image would rotate as the probe rotates, but the videoimage would always maintain orientation relative to the front and backof the patient, similar to orientation with the head and feet aspreviously described.

Positional sensors 84 and 86 can be any devices that produce electricalsignals indicative of the position of the probe 62. For example, thesesensors might have friction wheels that contact the probe 62 and thatare coupled to opto-electronic encoders or counters that produceelectrical signals. Another method of sensing position might be to put aseries of dots, lines, or other marks directly on the shaft of theultrasound probe 62 and to optically detect the motion of these marksusing reflective encoders as position sensors 84 and 86.

In addition, or alternatively, to rotational position sensor 84, whichis mounted at the surgical port, a rotational sensor that is sensitiveto gravitational force could be placed within the probe. Preferably,such a gravitationally sensitive sensor 88 would be positioned near thefirst terminal end in the vicinity of the array 76. Alternatively, sucha gravitationally sensitive sensor 90 could be placed in the handle 70attached to the probe 62.

One suitable gravitationally sensitive position sensor is a switchhaving an electrically conductive mass, such as a ball of liquid mercuryor a solid metal ball, that is capable of responding to gravitationalforce to close one of several contacts in the switch. FIG. 5 shows aswitch 92 actuated by a ball of mercury. As a probe with the mercuryswitch 92 is rotated, a ball of mercury 94 in mercury switch 92 movessuch that the mercury is always at the position of the switch pointingin a downward direction in response to the gravitational force. Themercury switch will, therefore, complete the circuit with the contactthat is pointing down and an electrical signal will be generated in thecircuit completed by the contact and the electrical signal istransmitted to a processor 98 where it is used to orient an ultrasonicvideo display on video monitor 100. Rotation of the ultrasound videoimage is as described previously for rotational position sensor 84 asshown in FIG. 4.

As previously discussed, a reference point can be established fororientation of a video ultrasound image relative to the patient. Thereference point for the position sensors can be established in either anabsolute or a relative sense. For example, if a rotational positionsensor is used that responds to gravity, then image orientation can beestablished with respect to actual up/down orientation. If however, theposition sensor consists of either an optical or mechanical encoder,then in order to establish a reference position, the system operatorwould have to move the probe into a predetermined position (i.e., imageplane from front to back) and then notify the system by means of aswitch or contact closure, via an operator interface 101 with processor78, that the probe is in the reference position.

In a further aspect, the present invention provides a probe for internaluse in medical operations, and particularly for use with laparoscopicsurgery, that includes both a surgical device and an ultrasonic devicewith a field of imaging that either includes the surgical device or isimmediately adjacent to the surgical device. In one embodiment, thesurgical device is a tool designed for cutting and/or cauterizingtissue, such as, for example an electrocautery hook, a laser, or anultrasonic cutter. Combining a surgical device in close proximity withan ultrasonic device on a probe is particularly advantageous when thesurgical device is designed to cut and/or cauterize tissue, because thecombination provides close control of the cutting operation to assurethat only the intended tissue is actually cut and/or cauterized.

FIG. 6 shows one embodiment comprising an electrocautery hook. The probe102 has a carrier 104 with a longitudinal axis 106 extending between afirst terminal end 108 that enters into a patient's body and a secondterminal end, not shown, that remains outside of the patient's body.Mounted at the first terminal end 108 is an electrocautery hook 110 thatis connected to electrical wires 112 that supply electricity to theelectrocautery hook to provide the required thermal energy for cuttingand/or cauterizing tissue. Also mounted near the first terminal end isan array 114 having a plurality of ultrasonic transducer elementsconnected to electrical wires 116 that transmit electrical signals thatare representative of an ultrasonic signal received by the array 114that can be processed and displayed on a video monitor.

The ultrasonic transducer array 114 is mounted on the carrier in such amanner that the field of imaging includes the tip of the electrocauteryhook 110. Therefore, a surgeon using such a probe would be able tosimultaneously view the tissue to be cut and the tip of theelectrocautery probe. The surgeon would, therefore, have a high degreeof control in assuring that only the proper tissue is cut.

In some instances, it may be desirable to have improved side imagingcapabilities. In such cases, it may be desirable to orient the field ofimaging such that it does not actually include the surgical device, butis adjacent to the surgical device in such a manner that the surgeon cancarefully control the location and operation of the surgical device toassure that the proper operation is performed. In some applications, itwill be desirable to combine forward and side imaging capabilities usingan ultrasonic transducer array combining both forward and side imagingfeatures as previously discussed.

In yet a further aspect, the present invention provides an apparatus,such as a probe useful in laparoscopic surgery, and a method forestablishing an ultrasonic circuit to facilitate ultrasonic imaging ofbody tissue of interest. The apparatus comprises a carrier, anultrasonic device mounted on the carrier, and means for injecting anultrasonically transmissive medium adjacent to the ultrasonic device.

FIGS. 7 and 8 show a probe 120 having an array 122 of ultrasonictransducers and two lumens 124 passing through the carrier 126. Thelumens 124 are used to transmit an ultrasonically transmissive medium136 to openings 128 adjacent to the array 122 of transducer elements.

In the case of laparoscopic surgical operations, the probe 120 would beinserted into the patient's body and moved to a position as close aspossible to tissue 138 of interest for the purpose of obtaining anultrasonic image of that tissue. To establish, or to improve, ultrasoniccontact between ultrasonic transducers of the array 122 and the tissue138 of interest, an ultrasonically transmissive fluid is injectedthrough the lumens 124 such that the ultrasonically transmissive fluidexits from openings 128 adjacent to the transducer array 122.Consequently, the ultrasonically transmissive fluid can establish anultrasonic circuit between the array 122 and tissue 138 in the field ofview of the array.

The transmissive medium can be any substance that is ultrasonicallytransmissive and capable of being injected through the lumens 124.Although water is ultrasonically transmissive, in one embodiment ahigher viscosity fluid is used to reduce the tendency of thetransmissive medium to disperse or flow away from the immediate vicinityof the transducer array 122. In one embodiment, a high viscosity fluidthat has a viscosity of greater than about 20,000 cP, and preferablyfrom about 20,000 cP to about 80,000 cP. One suitable high viscosityfluid include, for example, is sodium hyaluronate, having a viscosity ofapproximately 40,000 cP. Preferably, the high viscosity fluid, afterbeing injected through the openings 128, adheres to the surface of thetransducer 122 array and to the carrier 120 in the immediate vicinity,thereby forming an ultrasonically transmissive circuit between thetransducer array 122 and the tissue 138 in the field of view of thetransducer array 122 with little, if any, of the high viscosity fluiddispersing or flowing away from the area in the immediate vicinity ofthe transducer array and the tissue of interest. After imaging of tissueof interest is complete, the high viscosity fluid can be removed byapplying suction to the lumens 124.

In one aspect, the present invention provides a disposable sheath forcovering a probe, particularly for covering a laparoscopic probe havingan ultrasonic device. The sheath covers the probe, thereby reducing oreliminating the need to sterilize the probe after use. The sheath coversthe probe and extends from at least the terminal end of the probe thatis inserted into the body cavity to a point on the probe that remainsoutside of the body cavity at all times. Preferably, the sheath coversthe entire length of the probe.

FIGS. 9A and 9B show a perspective view and a cross sectional view alongthe longitudinal axis of a rigid sheath 140 that is of a tubular shapedesigned to cover a generally tubular shaped laparoscopic probe havingan ultrasonic device. The rigid sheath 140 has a first terminal end 142that is inserted into a patient's body cavity along with the probe and asecond terminal end 144 that remains outside of the body at all times.To cover a laparoscopic probe with the rigid sheath 140, the probe isinserted into the internal, hollow space 146 of the sheath. The rigidsheath 140 is preferably shaped to provide a close fit to the probe tobe covered. Therefore, a tubular shaped sheath should be used to cover atubular probe. Also, the fit between the laparoscopic probe and therigid sheath should be of a close tolerance. Preferably, the maximumoutside diameter of a tubular probe to be inserted into a tubular sheathshould be not more than about 0.15 mm smaller than the internal diameter148 of the rigid sheath 140.

The sheath 150, is preferably keyed with and latched to the probeinserted into the sheath in any fashion that prevents the sheath and theinserted probe from moving relative to one another during use of theprobe. For example, the portion of probe, or the probe handle, whichremain outside of the body during use could have a protrusion thatcorresponds to a keyed slot or recess in the sheath. The protrusioncould also be spring actuated, for example, to latch into a recess inthe sheath, thereby preventing the sheath and probe from moving relativeto one another in either a rotational or translational direction.

The outer diameter 150 of the rigid sheath is smaller than the insidediameter of a cannula or surgical port. Preferably, the outer diameter150 of the rigid sheath is not more than about 0.15 mm smaller than thediameter of the surgical port, being defined by the inner diameter ofthe smallest restriction through the cannula.

The rigid sheath 140 has a thin wall 152 that is preferably no greaterthan about 0.4 mm in thickness. The rigid sheath 140 can be made of anymaterial, or combinations or composites of materials, that either aloneor in combination with the tubular shape of the sheath provide thedesired rigidity. By rigidity, it is meant that the structure of thesheath is such that material of the sheath will not bunch up, such as infolds, as would be experienced with a thin-walled, highly flexiblesheath made of elastomeric-type material such as latex rubber, which canbe sterilized. Rather, the rigid sheath 140, is a generally aself-supporting structure that resists such bunching of the material ofthe sheath. Therefore, the rigid sheath 140 reduces, or substantiallyeliminates, the binding problem associated with insertion and extractionof a probe covered by a sheath into and out of a patient's body throughthe cannula. Suitable materials for manufacture of the rigid sheathinclude, for example, metals, including steel, and relatively nonelasticpolymeric compositions, such as those containing polycarbonates orpolyethylenes. Polycarbonate-based compositions are particularlypreferred because of the high biocompatibility and transparency ofpolycarbonates. Although transparency is not required, it is desirableso that the fit of the probe into the sheath can be observed at the timethe probe is covered by the sheath.

FIGS. 10A and 10B show a cross sectional view along the longitudinalaxis and a cross sectional view perpendicular to the longitudinal axisof a second sheath 154 having a first interior, hollow space 156 inwhich a probe can be inserted prior to entry into a body cavity andsecond interior, hollow space 158 that is a lumen useful fortransmitting fluids or surgical tools, such as a biopsy needle, to thearea adjacent to the end of the probe, such as near the ultrasoundimaging area of the probe. The sheath 154 is preferably a rigid sheath,as previously described.

FIG. 11 shows a third sheath 160 that is similar to the sheathpreviously described and shown in FIGS. 10A and 10B, except that thesheath 160 has a chamber 162 that contains an ultrasonicallytransmissive medium, such as a viscous fluid or deaerated water. Thechamber is sealed and partitioned from other interior space of thesheath 164 by a thin membrane 166. The thin membrane 166 may bemanufactured from any suitable material that is capable of sealing thechamber 162, but that can be pierced and ruptured by applying force tothe membrane, such as by forcing a probe inserted into the sheathagainst and through the membrane 162. Suitable materials formanufacturing of the membrane 166 include, for example, polyethylene andpolyvinyl chloride films.

FIG. 12 shows the same sheath 160, but after the thin membrane 166 hasbeen broken by insertion of an ultrasonic probe 170. Upon breaking thethin membrane 166, the probe is forced into the chamber 162 such thatthe transducer device of the probe is surrounded by ultrasonicallytransmissive medium that forms an ultrasonic circuit between theultrasonic device and the sheath 160.

FIG. 13 shows a fourth sheath 172 having attached at the terminal end,which enters into the body cavity, a balloon 174 that is made of anelastomeric-type material, such as latex rubber. The balloon 174 is influid communication with both the interior space 176 in which a probecan be inserted and a lumen 178 through which transmissive medium can beinjected to inflate the balloon 174. The sheath 172 also has a sealingdevice 180 for sealing around the outer surface of a probe insertedthrough the sealing device 180. Such a sealing device could be, forexample, an o-ring, chevron seals, or the like.

FIG. 14 shows the same sheath 172 in which an ultrasonic probe 182 hasbeen inserted. The probe 182, as shown, has been inserted through thesealing device 180 to form an annular seal about the outer surface ofthe probe 182. The balloon 174 has been inflated by the injection ofultrasonically transmissive medium through lumen 178, such that theultrasonic device of probe 182 is surrounded by ultrasonicallytransmissive medium that establishes an ultrasonic circuit between theultrasonic device and the balloon 174. By contacting the balloon withtissue of interest, an ultrasonic circuit can be established between thetissue and the ultrasonic probe. Also, the standoff distance providedbetween the inflated balloon and the ultrasonic device can significantlyenhance ultrasound imaging.

FIG. 15 shows a cross section that is perpendicular to the longitudinalaxis of a fifth sheath 184. The sheath 184 has two lumens 186 throughwhich ultrasonic medium can be transmitted to and injected adjacent tothe sheath, preferably at a distance along the longitudinal axis of thesheath corresponding to the position of an ultrasonic device on a probeinserted into the sheath. Preferably, ultrasonic medium injected throughlumens 186 establishes an ultrasonic circuit between the sheath 184 andtissue of interest to be ultrasonically imaged. Preferably, a probeinserted into sheath 184 is positioned such that an ultrasonic device onthe probe would be situated at a distance along the sheath'slongitudinal axis that corresponds with the area where ultrasonic mediuminjected through lumens 186 would exit the sheath.

Suitable transmissive medium, would be any medium capable oftransmitting ultrasound images, as previously discussed. In one case,the ultrasonically transmissive medium would be a high viscosity fluidthat would adhere to the sheath following injection from lumens 186 insuch a manner that the ultrasonically transmissive medium would notdisperse or flow away from the sheath 184, and therefore, could bereadily removed by suction through lumens 186 following ultrasoundimaging.

Additionally, to establish an ultrasonic circuit between the ultrasonicdevice of a probe inserted into the sheath 184 and the sheath 184, anultrasonically transmissive medium could be placed inside the interiorspace 188 of sheath 184.

The shape of sheath 184 is preferably designed so that the shape of theprobe to be inserted into the sheath 184 and the shape of the sheath 184are keyed so that the inserted probe and sheath can be rotated as a unitwith the ultrasonic device of the probe correspondingly located to theposition of the sheath 184 where ultrasonically transmissive medium maybe injected through the lumens 186. For example, flat surface 190 of thesheath 184 could be keyed to a close tolerance probe design alsocontaining a corresponding flat surface which contains an ultrasonicdevice.

Any aspect of the invention can be combined in any way with otheraspects. Any of the features of probes shown in FIGS. 1A, 1B, 2A, 2B, 3,6, 7 and 8 can be combined with image orientation and translation, asshown in FIG. 4, and/or any of the sheaths shown in FIGS. 9A, 9B, 10A,10B, 11, 12, 13, 14 and 15, making appropriate modifications, asnecessary. For example, a probe having a curved array portion and alinear array portion could be inserted into a rigid sheath having anelectrocautery probe attached to the sheath with electrical wires tooperate the sheath passing through a lumen attached to the sheath.

In a further aspect, the present invention provides a medical surgicalapparatus that is useful in performing endosurgical operations. Theapparatus is particularly useful for performing biopsies and othersurgical operations.

FIG. 16 shows generally a medical endosurgical apparatus 200, inexpanded view, that has both ultrasonic imaging and biopsy capabilities.Generally, the apparatus 200 includes an ultrasonic imaging probe 202for positioning an ultrasonic device adjacent to the tissue of interestso that an ultrasonic image of the tissue can be obtained. Theultrasonic imaging probe 202 includes a rod-shaped carrier 204 which hasan insertion tip 206 with an ultrasonic device 208 for insertion into apatient's body during a medical endosurgical operation. The ultrasonicimaging probe 202 also has a handle 210 attached to the carrier 204 foruse by a surgeon in grasping the probe and manipulating the location andpositioning of the ultrasonic device 208 in a patient's body toultrasonically image the tissue of interest.

A biopsy needle assembly 212 is used with the apparatus 200 for taking abiopsy sample of the tissue of interest. At one end of the biopsy needleassembly 212 are needle sampling tips 214 for insertion into thepatient's body to obtain the tissue sample. At the other end are needlehubs 216 which remain outside of the patient's body for manipulation ofthe needle sampling tips 214.

The apparatus 200 further includes a rigid sheath 218, with a lumen 220,that can be placed over the carrier 204 of the ultrasonic imaging probe202 for orienting the biopsy needle assembly 212 relative to the tip end206 of the ultrasonic imaging probe 202 so that the needle sampling tips214, when inserted through the lumen 220, are positioned within thefield of view of the ultrasonic device 208. The rigid sheath 218 and theultrasonic imaging probe 202 are engaged with one another in a keyedfashion to properly orient the lumen 220 of the rigid sheath 218 to theultrasonic imaging probe 202.

Also included in the apparatus 200 is a biopsy actuator 222 for firingthe biopsy needle assembly 212 to take a biopsy sample. The biopsyactuator 222 may be mounted on probe handle 210 so that a surgeon maygrasp and manipulate both the ultrasonic imaging probe 202 and thebiopsy actuator 222 with a single hand. The needle hubs 216 are disposedin biopsy actuator 222 and, when biopsy actuator 222 is fired, theneedle sampling tips 214 are correspondingly moved to take a biopsysample.

FIGS. 17-20 are used to further describe one embodiment of theultrasonic imaging probe 202. Referring to FIG. 17, the ultrasonicimaging probe 202 has the rod-shaped carrier 204 for insertion into apatient's body. Mounted adjacent the insertion tip 206 of the carrier204 is the ultrasonic device 208 for receiving an ultrasonic signal fromthe tissue underlying the ultrasonic device 208 that is representativethereof and for generating an electrical signal that is representativeof the received ultrasonic signal. The electrical signal is used toprepare an ultrasonic image of the underlying tissue within the bodycavity. Ultrasonic device 208 may also transmit ultrasonic signalswhich, when reflected off of tissue within the field of view of theultrasonic device 208, provide ultrasonic signals for receipt byultrasonic device 208. The ultrasonic device 208 preferably comprisesthe capability to ultrasonically image tissue in front of the carrier204 and more preferably comprises an array of ultrasonic transducersarranged in a linear array portion 228 for imaging tissue to the side ofthe carrier 204 and a curved array portion 230 for imaging tissue infront of the carrier 204.

The carrier 204 is particularly suited for endosurgical procedures. Thecarrier 204 has a substantially circular cross-section over much of itslength to facilitate insertion through the substantially circularsurgical port, which is generally established by a trocar or similardevice. The substantially uniform circular cross-section also provides agood sealing surface to which an annular seal may be established betweenthe wall of the surgical port and the outside surface of the carrier.Such a seal can be effected while the carrier 204 is stationary andwhile the carrier is sliding through the surgical port. The carrier 204deviates from the substantially circular cross-section shape only nearthe insertion tip 206 where the ultrasonic device 208 is mounted in aposition that curves toward the insertion tip 206. All of the carrier204, however, including the ultrasonic device 208, lies within the arealboundary of the substantially uniform circular cross-section to permiteasy insertion and removal of all of the carrier 204 through thesurgical port. The outside diameter of the carrier 204 is also typicallysmaller than about 12 millimeters, and is preferably 10 mm or smaller,for easy insertion into the small diameter surgical ports used duringendosurgery.

The carrier 204 is attached to probe handle 210 which may be grasped bya surgeon to manipulate the position of ultrasonic device 208 in apatient's body. As shown in FIG. 18, probe handle 210 has a generallyrounded side 226 on the bottom providing a comfortable contour forgrasping by a surgeon and a flat side 236 on top for mounting of thebiopsy actuator 222 and for orienting probe handle 210 to the rigidsheath 218.

Grooved into the flat side 236 of the probe handle 210 is a slot 232 forreceiving a corresponding rail on a biopsy actuator 222 to mount thebiopsy actuator 222 on the probe handle 210 during a biopsy procedure.As shown in FIG. 17, ultrasonic device 208 is located on the side of thecarrier 204 that corresponds with flat side 236 of probe handle 210 sothat the portion of the biopsy needle assembly 212 that projects fromthe mounted biopsy actuator 222 is oriented with ultrasonic device 208.The portion of the biopsy needle assembly 212 that projects from themounted biopsy actuator 222 can then be positioned within the field ofview of ultrasonic device 208 to facilitate the taking of a biopsysample. Slot 232 extends longitudinally along flat surface 236 of probehandle 210, thereby permitting a biopsy actuator 222 to be slidablymounted such that the biopsy actuator 222 may be translatedlongitudinally on probe handle 210 for positioning the biopsy actuator222 relative to the ultrasonic imaging probe 202.

On the end of the probe handle 210 that is adjacent the carrier 204 is akeyed engagement structure 233 for engaging and orienting the rigidsheath 218, which is used with the ultrasonic imaging probe 202 during abiopsy procedure. The keyed engagement structure 233 of the ultrasonicimaging probe 202 and the cooperating structure of the rigid sheath 218are keyed to one another to orient to the rigid sheath and theultrasonic imaging probe 202 so that the lumen 220 extending through therigid sheath 218 is aligned with flat side 236 of probe handle 210 toguide the portion of the biopsy needle assembly 212 exiting the mountedbiopsy actuator 222 into the field of view of the ultrasonic device 208adjacent insertion tip 206. FIG. 19, a cross-sectional view of probehandle 210 at the keyed engagement structure 233, shows a rounded raisedlip 234 on the bottom of the handle 210 and a flat side 236 on the topof the handle 210. The raised lip 234 provides an engaging surface for acooperating rigid sheath engagement structure on the rigid sheath 218and the raised lip 234 and flat side 236, together, form a keyedengagement shape that, in cooperation with the rigid sheath 218engagement structure, orients the rigid sheath 218 to the probe 210.

Ultrasonic imaging probe 202 is further shown in a top view in FIG. 20showing probe handle 210 with slot 232 for mounting of the biopsyactuator 222 and with raised lip 234 and flat side 236 for engaging andkeying with the rigid sheath 218 that is placed over the carrier 204during biopsy procedures.

FIG. 21 shows a typical biopsy needle assembly 212 which can be usedwith the apparatus 200 to take a biopsy sample. The biopsy needleassembly 212 comprises two needles, a hollow needle 240, called acannula, and a solid needle 242, called a stylet, which is disposedinside of the cannula. The cannula 240 has a cutting tip 244 which isinserted into the patient's body during the taking of a biopsy sampleand a needle hub 246, which remains outside of the patient's body, formanipulating cutting tip 244. The stylet 242 has a piercing tip 248 forpiercing tissue inside of a patient's body during the taking of a biopsysample and a needle hub 250, which remains outside of the patient'sbody, for manipulating the piercing tip. The stylet 242 also has atissue sampling notch 252 in which a biopsy tissue sample can becollected.

In taking a biopsy sample with the biopsy needle assembly 212, thepiercing tip 248 of the stylet 242 is initially in a retracted positionsubstantially within the hollow interior of the cannula 240. The needlehub 250 of the stylet 242 is then moved relative to the needle hub 246of the cannula 240 such that piercing tip 248 of the stylet 242 exitsfrom the cannula 240 to pierce the tissue of interest with piercing tip248 and to fill tissue sampling notch 252 with the tissue to be sampled.The needle hub 246 of the cannula 240 is then moved relative to needlehub 250 of the stylet 242 so as to move the cutting tip 244 of thecannula 240 down over the tissue sample filling tissue sampling notch252 of the stylet 242, thereby severing the tissue sample from thepatient's body and holding the severed sample in tissue sampling notch252 which ends up substantially completely within the cannula 240. Thebiopsy needle assembly 212 can then be removed from the patient's bodyand the collected tissue sample can be recovered for analysis.

The apparatus 200 also includes a rigid sheath that can be placed overan ultrasonic imaging probe to facilitate the taking of biopsy samplesby facilitating positioning of the biopsy needle assembly 212 in thefield of view of an ultrasonic device 208 on the ultrasonic imagingprobe 202.

FIGS. 22-26 show one embodiment of the rigid sheath 218 having a hollowinterior in which the ultrasonic imaging probe 202 can be disposed.Referring first to FIG. 22, the rigid sheath 218 includes a firstportion 256 for fitting over the rod-shaped carrier 204 of ultrasonicimaging probe 202 and for inserting, with the rod-shaped carrier 204into a patient's body. The rigid sheath 218 also has a second portion258 for connecting the rigid sheath 218 to an ultrasonic imaging probe202 and for orienting the rigid sheath 218 to the ultrasonic imagingprobe 202 such that the portion of the biopsy needle assembly 212passing through the lumen 220 can be positioned in the field of view ofan ultrasonic device 208. FIG. 23A is a cross-section of first portion256 showing the lumen 220 attached to the inside wall of the rigidsheath 218. FIG. 23B shows a possible alternative cross-sectional viewfor the rigid sheath 218 in which the lumen 220 is placed within thewall of the rigid sheath 218, such as could result by co-extruding thelumen 220 with the interior hollow portion of the rigid sheath 218 usingan extruded plastic material of construction.

The rigid sheath 218 has a substantially circular cross-sectional shapeover the length of the first portion 256 to facilitate easy insertion,removal, and sealing relative to a surgical port in similar manner aspreviously discussed with the shape of the carrier 204 of the ultrasonicimaging probe 202. The lumen 220 is substantially entirely within thesubstantially circular cross-section so as not to interfere withinsertion, removal and sealing relative to the surgical port. Typically,the first portion of rigid sheath 218 has an outside diameter of no morethan about 2 millimeters larger than the diameter of carrier 204.Therefore, the first portion 256 of rigid sheath 218 might have anoutside diameter of 12 millimeters to correspond to a carrier 204 of 10millimeters in diameter.

Referring again to FIG. 22, the second portion 258 has a rigid sheathkeyed engagement structure 259 for engaging the corresponding engagementstructure 233 of the ultrasonic imaging probe 202 and orienting therigid sheath 218 relative to the ultrasonic imaging probe 202. The keyedengagement structure 259 includes a connecting clip 260 for snappingover and engaging the raised lip 234 on the ultrasonic imaging probe202. The sectional view in FIG. 24 shows the hollow lip shape of theconnecting clip 260 for engaging the raised lip 234 on the ultrasonicimaging probe 202.

As shown in FIG. 22, the keyed engagement structure 259 also has anorientation guide 262 which, together with connecting clip 260, forms akeyed shape for orienting the rigid sheath to the ultrasonic imagingprobe 202. Specifically, the connecting clip 260 and the orientationguide 262 of the rigid sheath 218 cooperate with the raised lip 234 andflat side 236, respectively, of the probe handle 210 to orient the rigidsheath 218 to the probe handle 210. When the rigid sheath 218 isconnected to the ultrasonic imaging probe 202, the rigid sheath 218 isoriented relative to the ultrasonic imaging probe 202 by the keyedengagement shape so that the biopsy needle assembly 212 passing throughthe lumen 220 will exit the first portion 256 of the rigid sheath 218 inthe field of view of the ultrasonic device 208 on the ultrasonic imagingprobe 210. The end view of the rigid sheath 218 in FIG. 25 further showsconnecting clip 260 and orientation guide 262 having substantially flatorientation surface 264.

Orientation guide 262, as shown in FIG. 25, also has a needle guide 266for guiding a biopsy needle assembly to the entry port of the lumen 220for easy insertion of the biopsy needle assembly 212 into the lumen 220.As shown in the sectional view in FIG. 26 of orientation guide 262, theneedle guide 266 is in the form of a flared recess, with the narrow endof the flare being positioned adjacent the entry port of the lumen 220to guide the biopsy needle assembly 212 into the lumen 220.

FIGS. 27 and 28 show another embodiment of the rigid sheath 218 with analternative design for connecting and orienting the rigid sheath 218 toan ultrasonic imaging probe 202. The rigid sheath 218, as shown in FIGS.27 and 28, is substantially the same as shown in FIGS. 22-26, except asnoted. In particular, FIGS. 27 and 28 show the rigid sheath 218 withkeyed engagement structure 259 including a pair of opposing connectingclips 260 having a hook-like shape on one side for engaging the raisedlip 234 on an ultrasonic imaging probe 202. Orientation guide 262 has asubstantially flat orientation surface 264, which in combination withconnecting clip 260, key the rigid sheath 218 to the flat side 236 andraised lip 234 of the ultrasonic imaging probe 202. The needle guide 266in the form of a flared recess helps guide a biopsy needle assembly foreasy insertion into the lumen 220.

The rigid sheath 218 has been described for use with the ultrasonicimaging probe 202 for performing a biopsy. The utility of rigid sheath218 is not limited, however, to use with the biopsy actuator 222. Forexample, the ultrasonic imaging probe 202 and the rigid sheath 218 canbe used without the biopsy actuator 222 to perform many endosurgicalprocedures. For example, a biopsy can be performed manually, without theaid of the automatic actuation provided by biopsy actuator 222, usingthe probe 202 and the rigid sheath 218.

The rigid sheath 218 can also be used to perform endosurgical proceduresother than biopsies in which it may be convenient to pass endosurgicaltools through lumen 220 for positioning within the field of view of theultrasonic device 208. Endosurgical tools, including a biopsy needleassembly, which can be passed through the lumen 220 are generallyreferred to as insertion devices. The rigid sheath 218 can be used withmany different types of insertion devices, whether manually orautomatically actuated. For example, a hollow needle can be passedthrough lumen 220 and positioned at a location of interest inside of apatient's body using the ultrasonic imaging capability of the ultrasonicdevice 208 of the ultrasonic imaging probe 202. A guide wire can then beinserted through the hollow needle for use in guiding subsequentinsertion devices, such as a cryoprobe or a catheter, to the location ofinterest inside of the patient's body cavity.

The rigid sheath of the present invention can be manufactured from anymaterial or materials having sufficient structural rigidity to preventsignificant flexure of the rigid sheath relative to an ultrasonicimaging probe disposed therein. Any materials are acceptable that arecapable of being shaped into the form of the rigid sheath of the presentinvention such that the rigid sheath is a self-supporting structure. Asused herein, self-supporting structure refers to a rigid sheathstructure that maintains substantially the same shape with an ultrasonicimaging probe inserted therein as the shape of the rigid sheath when itis free-standing, i.e., with no ultrasonic imaging probe disposedtherein. Examples of suitable materials include thermosettingcompositions such as epoxy glass composites and thermoplastics such aspolyesters, polycarbonates and rigidized PVC. Although the rigid sheathof the present invention may be sterilized for reuse, an advantage ofthe rigid sheath is that it can be made relatively inexpensively andcan, therefore, be economically disposed of after a single use, therebyavoiding the cost and complexity of sterilization for reuse.

The apparatus 200, as shown in FIG. 1, also includes the biopsy actuator222 that can be mounted on the handle 210 of an ultrasonic imaging probe202 to assist in accurately taking a biopsy sample with a biopsy needleassembly that is disposed in the biopsy actuator 222. More specifically,the biopsy actuator 222 is designed to be mounted on the handle 210 ofthe ultrasonic imaging probe 202 to facilitate grasping and manipulationwith one hand of both the biopsy actuator 222 and the handle 210 of theultrasonic imaging probe 202.

Referring to FIGS. 29-31, the biopsy actuator 222 includes a housing 272for containing the working mechanisms of the biopsy actuator 222 and forproviding a contoured surface for a surgeon to comfortably grasp. On oneside of housing 272 is a rail 274 which mates with the correspondingslot 232 on the handle 210 of an ultrasonic imaging probe 202 toslidably mount the biopsy actuator 222 on the probe handle 210. Slidablemounting of the biopsy actuator 222 on a probe handle 210 permits thesurgeon to translate the biopsy actuator 222 longitudinally along theprobe handle 210, thereby allowing positioning of the biopsy actuator222 relative to the probe handle 210 and, hence, also allowing theportion of the biopsy needle assembly 212 that projects from the biopsyactuator 222 to be positioned relative to an ultrasonic device 208adjacent the insertion tip of the ultrasonic imaging probe 202.

As shown in FIGS. 30 and 31, housing 272 has a generally rounded shapeon the side opposite rail 274. The rounded shape provides good contourfor grasping of the biopsy actuator 222 and the probe handle 210 onwhich the biopsy actuator 222 is mounted, which has the rounded side 226located opposite to the side on which the biopsy actuator 222 ismounted.

FIG. 32 is a cut-away of the biopsy actuator 222 showing the breachmechanism for firing the biopsy needle assembly 212 to take a biopsysample. The breach mechanism includes a cannula slide 278 for propellingthe cannula 240 of the biopsy needle assembly 212 during the taking of abiopsy sample. The cannula slide 278 is shown biased in a forwardposition by springs 280. The cannula slide 278 has a recess area 282 forreceiving the needle hub 246 of the cannula 240. The breach mechanismalso includes a stylet slide 284 for propelling the stylet 242 duringthe taking of a biopsy. The stylet slide 284 is shown biased in aforward position by springs 286. The stylet slide 284 has a recess area288 for receiving the needle hub 250 of the stylet 242. An opening 290through the wall of housing 272 is provided through which the cannula240 and the stylet 242 of the biopsy needle assembly 212 can extend fromthe needle hubs 246 and 250 which are held, respectively, in cannulaslide 278 and the stylet slide 284.

Biopsy actuator 222 also includes a cocking mechanism for retracting andretaining the cannula slide 278 against the force of compressed springs280 and for retracting and retaining the stylet slide 284 against theforce of compressed springs 286. The cocking mechanism includes a pairof cannula cocking grips 292 (shown in FIGS. 29, 32 and 34) for use inretracting the cannula slide 278 towards the back of biopsy actuator 222against the bias of springs 280 to cock the cannula slide 278. Thecannula cocking grips 292 are located on opposite sides of housing 272from each other to facilitate easy gripping of the cannula cocking grips292, such that one of the cannula cocking grips 292 can be gripped witha thumb and the other of the cannula cocking grips 292 can be grippedwith an opposing finger of the same hand. The cocking mechanism alsoincludes a cannula sear 294 pivotally attached to housing 272 and havingtwo cannula retaining arms 296 for retaining the cannula slide 278 in acocked position against compressed springs 280. Referring to FIG. 33,showing a sectional view of biopsy actuator 222 in a cocked position,the cannula retaining arms 296 have a hooked end 298 which hooks overthe cannula slide 278 to retain the cannula slide 278 in a cockedposition.

The cocking mechanism also includes a pair of stylet cocking grips 300(as shown in FIGS. 29, 32 and 34) for retracting the stylet slide 284towards the back of biopsy actuator 222 against the bias of springs 286to cock the stylet slide 284. The stylet cocking grips 300 are locatedon opposite sides of housing 272, to facilitate easy griping forcocking, in the same manner as previously described for the cannulacocking grips 292. The cocking mechanism also includes a stylet sear 302pivotally attached to housing 222 and having two stylet retaining arms304 for retaining the stylet slide 284 in a cocked position againstcompressed springs 286. As shown in FIG. 33, the stylet retaining arms304 have a hooked end 306 which hooks over the stylet slide 284 toretain the stylet slide 284 in a cocked position.

Biopsy actuator 222 also includes a firing mechanism for firing thebiopsy actuator to release the cannula slide 278 and the stylet slide284 from cocked positions, thereby propelling a stylet 242 and thecannula 240 of the biopsy needle assembly 212 to take a biopsy sample oftissue in a patient's body. Referring to FIGS. 32 and 33, the firingmechanism includes a firing button 308 on the back of the biopsyactuator 222. As shown in FIG. 33, firing button 308 contacts the styletsear 302 and when pushed, pivots the stylet sear 302 about pin 310,lifting the hooked end 306 of the sear 302 to release the stylet slide284 from a cocked position and allow spring 286 to expand, therebypropelling the stylet slide 284 to a forward position. The stylet slide284 eventually strikes the cannula sear 294, causing the cannula sear294 to pivot about pin 312 and lift hooked end 298, thereby releasingthe cannula slide 278 from a cocked position and allowing spring 280 toexpand, thereby propelling the cannula slide 278 towards the front ofthe biopsy actuator 222 in phased sequence to the propulsion of thecannula slide 284.

Biopsy actuator 222 also includes a safety locking mechanism forpreventing the accidental firing of the biopsy actuator 222 and lockingthe biopsy actuator 222 in place on the handle 210. Referring to FIGS.29 and 31, the safety mechanism includes a safety cover 316 whichnormally covers firing button 308. Safety cover 316 is pivotally mountedto housing 272 and is biased in a closed position by spring 318.Referring to FIGS. 35 and 36, safety cover 316 can be opened to exposefiring button 308 by pivoting safety cover 316 about pin 320.

FIGS. 35 and 36 show partial views of the biopsy actuator 222 mounted ona probe handle 210 of an ultrasonic imaging probe 202 that demonstratethe locking aspect of the mechanism. An additional feature of safetycover 316 is that it has a squared edge 322 which, upon pivoting ofsafety cover 316 to an "off-safety" position in which the firing button308 is exposed, wedges against the surface 324 of the probe handle 210with sufficient force to lock the biopsy actuator 222 in a fixedposition relative to the probe handle 210. As a consequence, the portionof the biopsy needle assembly 212 exiting the biopsy actuator 222 wouldalso be locked in position relative to the ultrasonic device 208 on theinsertion tip 206 of the ultrasonic imaging probe 202 to facilitateaccurately taking a biopsy sample of the desired tissue.

It should be recognized that the locking mechanism could be anymechanism capable of freezing the relative positions of the ultrasonicimaging probe 202 and the biopsy actuator 222. Such mechanisms include abreaking structure, a detent structure and others.

FIG. 34 shows a perspective view of assembled biopsy actuator 222 withthe housing 272 having a contoured shaped for easy grasping incombination with the rounded side 226 of the probe handle 210 and withthe cannula cocking grips 292 and the stylet cocking grips 300positioned on the side of the biopsy actuator 222 for easy cocking by asurgeon. When mounted on the probe handle 210 of the ultrasonic imagingprobe 202, the opening 290, through which the biopsy needle assembly 212would extend during use, is oriented to position the lumen 220 in therigid sheath 218 for receiving and guiding a portion of the biopsyneedle assembly 212 to within the field of view of the ultrasonic device208 on the insertion tip 206 of the ultrasonic imaging probe 202 overwhich the rigid sheath 218 is disposed.

Referring to FIG. 37, the assembled medical endosurgical apparatus 200is shown in perspective. The medical endosurgical apparatus 200 includesthe ultrasonic imaging probe 202 having the ultrasonic device 208located near the insertion tip 206 of the rod-shaped carrier 204.Disposed over the rod-shaped carrier 204 of the ultrasonic imaging probe202 is the rigid sheath 218 which engages the raised lip 234 of theprobe handle 210 with the connecting clip 260. The engaging surfaces ofthe probe handle 210 and rigid sheath 218 are keyed to orient the lumen220 of the rigid sheath 218 such that the needle sampling tips 214 ofthe biopsy needle assembly 212 passing through the lumen 220 arepositioned within the field of view of the ultrasonic device 208.

The biopsy actuator 222 is slidably mounted on the probe handle 210 byengaging the rail 274 of the biopsy actuator 222 with the correspondingslot 232 on the probe handle 210. As mounted, the probe handle 210 andthe biopsy actuator 222 together have a generally rounded contour foreasy grasping and manipulation of both with one hand by a surgeon. Theneedle hubs 246 and 250 of the biopsy needle assembly 212 are disposedin their respective slides in the biopsy actuator 222 and the cannula240 and the stylet 242 pass through the opening 290 in the wall of theactuator 222. The biopsy actuator 222 can be cocked using the pair ofcannula cocking grips 292 and the pair of stylet cocking grips 300mounted on opposite sides of the biopsy actuator 222. A biopsy of tissuenear the insertion tip 206 of the ultrasonic imaging probe 202 can betaken by firing the biopsy actuator 222, to propel the needle samplingtips 214 of the biopsy needle assembly 212 in phased sequence to firstpierce the tissue of interest and to then sever a sample of the tissuefor collection.

The present invention also includes a method for locating tissue ofinterest inside of a body cavity and taking a biopsy sample of thattissue of interest. The method includes fitting the ultrasonic imagingprobe 202 with the rigid sheath 218. The rod-shaped carrier 204 of theultrasonic imaging probe 202 and a first portion 256 of the rigid sheath218 are then inserted into the patient's body by a surgeon grasping theprobe handle 210. The surgeon then manipulates the ultrasonic imagingprobe 202, and thereby manipulates the ultrasonic device 208, toultrasonically image tissue within the patient's body. When the tissueof interest is identified, then the biopsy actuator 222 is fitted withthe biopsy needle assembly 212 and is mounted on the probe handle 210such that the needle sampling tips 214 of the biopsy needle assembly 212pass through the lumen 220 of the rigid sheath 218 and exit the lumen220 with the needle sampling tips 214 positioned within the field ofview of the ultrasonic device 208. The surgeon then cocks the biopsyactuator 222 using the cannula cocking grips 292 and the stylet cockinggrips 300. Checking to see that both the needle sampling tips 214 andthe tissue of interest are properly oriented to one another within thefield of view of the ultrasonic device 208, then the surgeon can pivotthe safety cover 316 to the "off-safety" position and also lock thebiopsy actuator 222 in position relative to the probe handle 210. Thesurgeon can then fire the biopsy actuator 222 to effect taking of thebiopsy sample with the needle sampling tips 214 by pressing the firingbutton 308. The safety cover 316 can then be closed, thereby releasingthe biopsy actuator 222 from its locked position to the probe handle210. The surgeon can then slidably remove the biopsy actuator 222 fromthe probe handle 210, and thereby extract the biopsy needle assembly 212from the patient's body along with the tissue sample taken.Alternatively, the surgeon can remove the entire medical endosurgicalapparatus 200, including the biopsy needle assembly 212, and the tissuesample can be recovered from the removed medical endosurgical apparatus200.

Preferred embodiments for the ultrasonic imaging probe, rigid sheath andbiopsy actuator have been described herein. It should be recognized,however, that the present invention is not so limited. Engagementstructure for engaging the rigid sheath and the ultrasonic imaging probecan be any structures, having any keyed engaging shapes, capable ofholding the rigid sheath and the ultrasonic imaging probe together andproperly aligning the rigid sheath to the ultrasonic imaging probe.Interconnection between the probe handle of the ultrasonic imaging probeand the biopsy actuator can be by any mechanism capable of holding theprobe handle and the biopsy actuator together and aligning the biopsyactuator and a biopsy collection device exiting the biopsy actuator withthe field of view of the ultrasonic device on the ultrasonic imagingprobe. Any biopsy collection device capable of being situated by abiopsy actuator mounted on the probe handle can be used with the medicalendosurgical apparatus of the present invention.

The foregoing description of the invention has been presented forpurposes of illustration and description. Further, the description isnot intended to limit the variations and modifications commensurate withthe above teachings, and the skill or knowledge in the relevant art arewithin the scope of the present invention. The preferred embodimentdescribed hereinabove is further intended to explain the best mode knownof practicing the invention and to enable others skilled in the art toutilize the invention in various embodiments and with the variousmodifications required by their particular applications or uses of theinvention. It is intended that the appended claims be construed toinclude alternate embodiments to the extent permitted by the prior art.

What is claimed is:
 1. A medical endosurgical apparatus havingultrasonic imaging and biopsy capabilities, the apparatus comprising:anendosurgical ultrasonic imaging probe having a first portion that has afirst shape which facilitates insertion thereof, during use, through asurgical port and into a body cavity, and a second portion that has asecond shape which substantially prevents insertion thereof, during use,through the surgical port and that remains outside of the body cavity,said first portion including ultrasonic means for receiving anultrasonic signal and generating an electrical signal that isrepresentative of the received ultrasonic signal and which may be usedto prepare an image of tissue within the body cavity, said secondportion including a probe handle for manipulating the probe, whereinsaid probe handle, due to said second shape, is substantially preventedfrom being inserted, during use, through said surgical port and remainsoutside the body cavity; biopsy actuator means for actuating a biopsycollection device that collects a tissue sample inside the body cavity;and means for facilitating readily physically interconnecting andreadily physically disconnecting said probe handle and said biopsyactuator means so that said endosurgical ultrasonic imaging probe can beused with or without said biopsy actuator means and, when used with saidbiopsy actuator means, forms an integrated unit.
 2. A medicalendosurgical apparatus, as claimed in claim 1, wherein:said firstportion comprises a first terminal end that is operatively connected tosaid second portion and a second terminal end that is inserted throughthe surgical port during use; wherein said first portion has asubstantially circular cross-section located between said first terminalend and said second terminal end; and wherein cross-sections of saidfirst portion at locations extending from said second terminal endtowards said first terminal end are less than or equal to saidsubstantially circular cross-section to facilitate use with a surgicalport.
 3. A medical endosurgical apparatus, as claimed in claim 2,wherein:said substantially circular cross-section has a diameter of lessthan about 10 millimeters.
 4. A medical endosurgical apparatus, asclaimed in claim 1, wherein:said ultrasonic means includes an array ofultrasonic transducers.
 5. A medical endosurgical apparatus, as claimedin claim 1, wherein:said ultrasonic means including an array ofultrasonic transducers with a first portion of said array of transducersarranged in a substantially linear fashion with respect to one anotherand a second portion of said array of transducers arranged in a curvewith respect to one another.
 6. A medical endosurgical apparatus, asclaimed in claim 1, wherein:said second portion includes a raised lipfor use in holding a sheath disposed over said first portion of saidendosurgical ultrasonic imaging probe in place.
 7. A medicalendosurgical apparatus, as claimed in claim 6, further comprising:asheath for covering said first portion of said endosurgical ultrasonicimaging probe and including means for engaging said raised lip.
 8. Amedical endosurgical apparatus, as claimed in claim 7, wherein:saidsheath is designed for disposal after a single use.
 9. A medicalendosurgical apparatus, as claimed in claim 1, wherein:said secondportion includes a raised lip for holding a sheath disposed over saidfirst portion of said endosurgical ultrasonic imaging probe in place,and includes a keyed shape that is used to orient the sheath relative tothe endosurgical ultrasonic imaging probe.
 10. A medical endosurgicalapparatus, as claimed in claim 9, wherein:said keyed shape includes acurved portion and a substantially straight portion.
 11. A medicalendosurgical apparatus, as claimed in claim 1, wherein:said means forfacilitating readily physically interconnecting and readily physicallydisconnecting includes a slot located on one of said probe handle andsaid biopsy actuator means, and a rail located on the other of saidprobe handle and said biopsy actuator means and capable of matinglyengaging said slot.
 12. A medical endosurgical apparatus, as claimed inclaim 1, wherein:said means for facilitating readily physicallyinterconnecting and readily physically disconnecting includes means forpermitting said biopsy actuator means to be moved relative to said probehandle so that the biopsy collection device can be moved to sample theappropriate tissue.
 13. A medical endosurgical apparatus, as claimed inclaim 1, wherein:said means for facilitating readily physicallyinterconnecting and readily physically disconnecting includes means forpermitting said biopsy actuator means to be moved relative to said probehandle when interconnected, so that the biopsy collection device can bemoved to sample the appropriate tissue and means for fixing the positionof said biopsy actuator means relative to said probe handle so that thebiopsy collection device samples the appropriate tissue.
 14. A medicalendosurgical apparatus, as claimed in claim 1, wherein:said probe handleincludes a longitudinally extending curved portion and a longitudinallyextending, substantially flat portion; wherein said means forfacilitating readily physically interconnecting and readily physicallydisconnecting positions said biopsy actuator means adjacent to saidlongitudinally extending, substantially flat portion of said probehandle; wherein said curved portion facilitates grasping of both saidprobe handle and said biopsy actuator means.
 15. A medical endosurgicalapparatus, as claimed in claim 1, wherein:said biopsy actuator meansincludes means for cocking a carrier that moves at least a portion ofthe biopsy collection device, said means for cocking including opposinggrips mounted on opposing surfaces of said biopsy actuator means tofacilitate cocking of the biopsy actuator means.
 16. A medicalendosurgical apparatus, as claimed in claim 1, wherein:said biopsyactuator means includes a first means for displacing a first portion ofthe biopsy collection device and a second means for displacing a secondportion of the biopsy collection device that is different than saidfirst portion of the biopsy collection device.
 17. A medicalendosurgical apparatus, as claimed in claim 1, wherein:said means forfacilitating readily physically interconnecting and readily physicallydisconnecting includes means for orienting said biopsy actuator means sothat the biopsy collection device can be positioned in the field of viewof said ultrasonic means.
 18. A medical endosurgical apparatus, asclaimed in claim 1, wherein:said means for facilitating readilyphysically interconnecting and readily physically disconnecting includesmeans for slidably interconnecting and disconnecting said biopsyactuator means and said probe handle.
 19. A medical endosurgicalapparatus, as claimed in claim 1, further comprising:a sheath forcovering said first portion of said endosurgical ultrasonic imagingprobe, said sheath having a cross-sectional shape suitable for insertionthrough a surgical port.
 20. A medical endosurgical apparatus, asclaimed in claim 1, further comprising:a sheath for covering said firstportion of said endosurgical ultrasonic imaging probe; and means forretaining said sheath to said endosurgical ultrasonic imaging probe toprevent displacement of said sheath during use.
 21. A medicalendosurgical apparatus, as claimed in claim 1, further comprising:asheath for covering said first portion of said endosurgical ultrasonicimaging probe that includes a lumen for receiving a biopsy collectiondevice, wherein said lumen has an exit port; and said biopsy actuatormeans includes means for moving at least a portion of the biopsycollection device beyond said exit port.
 22. A medical endosurgicalapparatus having ultrasonic imaging and biopsy capabilities, theapparatus comprising:an endosurgical ultrasonic imaging probe having afirst portion designed for insertion, during use, into a body through asurgical port and a second portion designed for remaining outside of thebody cavity during use, said first portion including ultrasonic meansfor receiving an ultrasonic signal and generating an electrical signalthat is representative of the received ultrasonic signal and which maybe used to prepare an image of tissue within the body cavity, saidsecond portion including a probe handle for manipulating the probe;biopsy actuator means for actuating a biopsy collection device thatcollects a tissue sample inside the body cavity; means for physicallyinterconnecting with said probe handle and said biopsy actuator means;said second portion includes a raised lip for holding a sheath disposedover said first portion of said endosurgical ultrasonic imaging probe inplace, and includes a keyed shape that is used to orient a sheathrelative to the endosurgical ultrasonic imaging probe; and a sheath forcovering said first portion of said endosurgical ultrasonic imagingprobe, said sheath includes a lumen for receiving a biopsy collectiondevice and means for engaging said raised lip to hold said sheath inplace relative to the endosurgical ultrasonic imaging probe, said meansfor engaging having a complementary keyed shape to said keyed shape ofsaid endosurgical ultrasonic imaging probe so that, upon engagement ofsaid raised lip and said means for engaging, said lumen is oriented sothat the biopsy collection device can be disposed in the field of viewof the ultrasonic means.
 23. A medical endosurgical apparatus, asclaimed in claim 22, wherein:said sheath having a cross-sectional shapesuitable for insertion through a surgical port.
 24. A medicalendosurgical apparatus having ultrasonic imaging and biopsycapabilities, the apparatus comprising:an endosurgical ultrasonicimaging probe having a first portion designed for insertion, during use,into a body through a surgical port and a second portion designed forremaining outside of the body cavity during use, said first portionincluding ultrasonic means for receiving an ultrasonic signal andgenerating an electrical signal that is representative of the receivedultrasonic signal and which may be used to prepare an image of tissuewithin the body cavity, said second portion including a probe handle formanipulating the probe; biopsy actuator means for actuating a biopsycollection device that collects a tissue sample inside the body cavity;means for physically interconnecting with said probe handle and saidbiopsy actuator means; and a sheath for covering said first portion ofsaid endosurgical ultrasonic imaging probe and including a lumen forreceiving a biopsy collection device that is actuated by said biopsyactuator means.
 25. A medical endosurgical apparatus, as claimed inclaim 24, wherein:said biopsy actuator means includes a first means fordisplacing a first portion of the biopsy collection device and a secondmeans for displacing a second portion of the biopsy collection devicethat is different than said first portion of the biopsy collectiondevice.
 26. A medical endosurgical apparatus, as claimed in claim 24,wherein:said means for physically interconnecting includes means fororienting said biopsy actuator means so that the biopsy collectiondevice can be positioned in the field of view of said ultrasonic means.27. A medical endosurgical apparatus, as claimed in claim 24,wherein:said means for physically interconnecting includes means forpermitting a location of said biopsy actuator means relative to saidprobe handle to be changed and thereby, when in use, permit a locationof the biopsy collection device relative to said ultrasonic means to bechanged.
 28. A medical endosurgical apparatus, as claimed in claim 27,wherein:said means for physically interconnecting includes means forfixing the location of said biopsy actuator means relative to said probehandle.
 29. A medical endosurgical apparatus, as claimed in claim 24,wherein:said sheath having a cross-sectional shape suitable forinsertion through a surgical port.
 30. A medical endosurgical apparatus,as claimed in claim 24, further comprising:means for retaining saidsheath to said endosurgical ultrasonic imaging probe to preventdisplacement of said sheath during use.
 31. A medical endosurgicalapparatus, as claimed in claim 24, further comprising:means fororienting said sheath relative to said endosurgical ultrasonic imagingprobe so that, when a biopsy collection device is located in said lumen,the biopsy collection device can be positioned in the field of view ofsaid ultrasonic means.
 32. A medical endosurgical apparatus havingultrasonic imaging and biopsy capabilities, the apparatus comprising:anendosurgical ultrasonic imaging probe having a first portion that has afirst shape which facilitates insertion thereof, during use, through asurgical port and into a body cavity, and a second portion that has asecond shape which substantially prevents insertion thereof, during use,through the surgical port and that remains outside of the body cavity,said first portion including ultrasonic means for receiving anultrasonic signal and generating an electrical signal that isrepresentative of the received ultrasonic signal and which may be usedto prepare an image of tissue within the body cavity, said secondportion including a probe handle for manipulating the probe, whereinSaid probe handle, due to said second shape, is substantially preventedfrom being inserted, during use, through said surgical port and remainsoutside the body cavity; wherein said second portion of said probeincludes means for facilitating readily engaging and readily disengagingone of the following: a sheath that can be disposed over said firstportion of said ultrasonic imaging probe or a biopsy actuator means foractuating a biopsy collection device.
 33. A medical endosurgicalapparatus, as claimed in claim 32, wherein:means for facilitatingreadily engaging and readily disengaging includes one of the following:a groove or a rail for engaging a biopsy actuator means.
 34. A medicalendosurgical apparatus as claimed in claim 32, wherein:said means forfacilitating readily engaging and readily disengaging includes a raisedlip for engaging a sheath.
 35. A medical endosurgical apparatus havingultrasonic and biopsy capabilities, the apparatus comprising:anendosurgical ultrasonic imaging probe having a first portion that has afirst shape which facilitates insertion thereof, during use, through asurgical port and into a body cavity, and a second portion that has asecond shape which substantially prevents insertion thereof, during use,through the surgical port and therefore remains outside of the bodycavity, said first portion including ultrasonic means for receiving anultrasonic signal and generating an electrical signal that isrepresentative of the received ultrasonic signal and which may be usedto prepare an image of tissue within the body cavity, said secondportion including a probe handle for manipulating the probe, whereinsaid probe handle, due to said second shape, is substantially preventedfrom being inserted, during use, through said surgical port andtherefore remains outside the body cavity; biopsy actuator means foractuating a biopsy collection device that collects a tissue sampleinside the body cavity; means for facilitating readily physicallyinterconnecting and readily physically disconnecting said probe handleand said biopsy actuator means so that said endosurgical ultrasonicimaging probe can be used with or without said biopsy actuator meansand, when used with said biopsy actuator means, forms an integratedunit; wherein said means for facilitating readily physicallyinterconnecting and readily physically disconnecting includes means fororienting said biopsy actuator means to said endosurgical ultrasonicimaging probe so that the biopsy collection device can be positioned inthe field of view of said ultrasonic means; wherein said means forfacilitating readily physically interconnecting and readily physicallydisconnecting includes means for permitting a location of said biopsyactuator means relative to said probe handle to be changed and thereby,when in use, permit a location of the biopsy collection device relativeto said ultrasonic means to be changed; wherein said means forfacilitating readily physically interconnecting and readily physicallydisconnecting includes means for fixing the location of said biopsyactuator means relative to said probe handle; a sheath for covering saidfirst portion of said ultrasonic imaging probe; wherein said sheath hasa cross-sectional shape suitable for insertion through a surgical port;wherein said sheath includes a lumen for receiving the biopsy collectiondevice that is actuated by said biopsy actuator means; means forretaining said sheath to said endosurgical ultrasonic imaging probe toprevent displacement of said sheath during use; and means for orientingsaid sheath relative to said endosurgical ultrasonic imaging probe sothat, when a biopsy collection device is located in said lumen, thebiopsy collection device can be positioned in the field of view of saidultrasonic means.